Sunday, 26 November 2006

Princess Health and  More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

Princess Health and More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

The latest development in the mess at the University of Medicine and Dentistry of New Jersey (UMDNJ) produced some interesting analysis in the media. As we have discussed previously, the university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) The latest development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities.

First, the indefatigable Newark Star-Ledger reported that Dr Jerrold Ellner, the chair of medicine at the UMDNJ Newark campus, was put on administrative leave because he and Ronald Pittore, of the school's legal department, "were identified by the university's federal monitor as key figures in UMDNJ's plan to hire at least 18 local cardiologists as part-time clinical assistant professors."

That event inspired a news analysis article in the New York Times. The points it made included,

As New Jersey�s state medical school has been shaken in the past year by disclosures of widespread financial mismanagement, administrators there have repeatedly defended the institution, the University of Medicine and Dentistry of New Jersey, by insisting that the scandals have affected its treasury but not the quality of care for the more than two million patients it treats each year.

But a federal monitor�s recent accusations that the cardiology unit at the university�s main hospital has been paying kickbacks to doctors for referring heart patients have undercut that argument at a time when the school�s future remains in doubt.

The fact that some of the university�s most prominent doctors now stand accused of taking part in an illegal scheme that involved life-or-death medical decisions is likely to further tarnish the school�s image at a time when state officials are deciding whether to merge the institution with Rutgers University and Robert Wood Johnson University Hospital.

Governor Corzine said on Wednesday that charges about the quality of care being affected by the scandal were deeply troubling � 'It�s really disgusting that the culture allowed for this kind of practice' � but added that he had not decided whether to restructure or disband the school.
But other state officials said the latest round of disclosures would only heighten pressure for a merger.

'This just highlights the disaster of trying to salvage what�s left,' said State Senator Raymond J. Lesniak, a Democrat from Union County who is chairman of a panel examining the future of the school. 'Before, the focus was on enhancing the ability to provide education. But now we�re also talking about direct impact on health care and people�s lives.'

On one hand, it is too bad that this analysis appeared in the Times' regional section. Although one would think that a scandal of this magnitude involving the biggest health care university in the US would attract national attention, as an example of the anechoic effect, it has been treated largely as a regional matter.

On the other hand, the analysis recounts some curious ideas about this case.

The first is that a scandal involving top leaders of the health care university had only financial significance, at least until a top physician leader was involved. Underlying this might be an asumption that the managerial and financial sphere of the university is entirely separate from the clinical and academic sphere. But the mismanagement in the former sphere must have sapped resources from the latter. Furthermore, it is hard to believe that clinical and academic personnel did not sense something wrong in the top management, and at least that the focus was more on the personal interests of the top management than the mission of the university. Such a sense would likely at least have dispirited these personnel, and certainly would not have enhanced their performance.

The second curious notion was that the involvement of a top physician-leader somehow signifies that the institution is now irredeemable, and the only remaining choices are to merge it into another institution, or shut it down entirely. This seems to discount, again, all the hard-working clinical and academic personnel who have been laboring to keep things together at UMDNJ together despite the bad behavior by top management. Maybe somebody should talk to this long-suffering group before any irrevocable decisions are made about the structure of the institution. And again, for better or worse, all should remember that health care institutions are made up of many dedicated hard-working people, besides the top managers. Perhaps again the underlying assumption is that somehow imperial top management is indistinguisable from the institution, the notion that "l'hospital c'est moi."

This notion must be discarded in favor of health care governance that is more representative of the relevant stake-holders, as well as more accountable, transparent, and ethical.

Saturday, 25 November 2006

Princess Health and  Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine. Princessiccia

Princess Health and Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine. Princessiccia

The latest issue of the New England Journal of Medicine includes an article about Bayer's attempted suppression of data from an observational study of Trasylol (aprotinin). [Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med 2006; 355: 2169-2171] We had first blogged about this case, based on a story reported in September, 2006 in the New York Times, here. Avorn's comments on the case are notable:

The health care system has a hard time performing drug-safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them, and despite the $220 billion we spend on drugs each year, we apparently can't find the resources to provide public support for these studies, even if the results could be of great clinical importance and save millions of dollars.

Avorn suggested:

A good start would be to make a national commitment to publicly supported studies of drug risks so that no company could take possession of critical findings for its own purposes. The results of that research could be discussed openly at an annual conference on the risks and benefits of drugs.

In my humble opinion, it does not make sense to let pharmaceutical (and bio-technology and device) companies be responsible for performing relatively unmonitored studies on human subjects to test their own products. One solution would be to put scientists, physicians, and organizations who are not beholden to such companies in charge of such studies. Another would be much more intense regulation of any human studies sponsored by commercial firms.

At least this issue has now come out in the perhaps world's most prestigious medical journal, so it is squarely in front of doctors, other health professionals, and health policy makers.

But I now realize that Avorn's article, and, for that matter, my previous post, both seemed to avoid the issue of accountability of the drug, bio-tech, and device companies who are currently performing (or funding, and then at least partically controlling) studies on humans. So let me correct that omission.

Also in my humble opinion, as long as commercial firms (e.g., pharma, bio-tech, or device) sponsor, and to any extent control studies on human beings, these firms should be held accountable for any failure to disseminate study findings, even if, and maybe especially if the findings are not favorable to their product. Because their products affect peoples' health and safety, suppressing data about their products' adverse effects, or failure to provide beneficial effects is an affront to any patient who might take or be subject to such products. There should be severe negative consequences for any company that withholds such findings.

Wednesday, 22 November 2006

Princess Health and  Cyberonics' Top Leaders Forced Out Over Back-Dated Stock Options. Princessiccia

Princess Health and Cyberonics' Top Leaders Forced Out Over Back-Dated Stock Options. Princessiccia

We had previously posted about the curious way in which Cyberonics' vagus nerve stimulator device was assessed as a treatment for severe depression by a US Food and Drug Administration (FDA) panel. Although a randomized controlled trial failed to show any improvements due to the device that could not be explained by chance alone, after some emotional patient testimonials, the panel voted to approve the device. One panelist later said it was "nuts."

We also posted about questions regarding the authors of an article sponsored by the company about the vagus nerve stimulator. These questions revolved around undisclosed conflicts of interest, and the extent a ghost-author was responsible for the article.

Cyberonics also came to our attention because of questions about stock-options granted to its top executives. Now, according to the Houston Chronicle,
Two top executives have exited Cyberonics, after it disclosed that its stock options problems are much broader than previously reported.

On Monday, investors bid up shares of the Houston-based medical device maker, which said Chairman and CEO Robert Cummins and Chief Financial Officer Pamela Westbrook resigned.

The duo was replaced, on an interim basis, by three people: Tony Coelho as chairman, Reese Terry Jr. as chief executive and John Riccardi as chief financial officer. George Parker was appointed as interim chief operating officer.

The personnel changes came as Cyberonics reported widespread stock option problems in a filing Friday with the U.S. Securities and Exchange Commission.

Before Friday, the company had acknowledged only one instance where stock options were at issue. Those options were given to top executives in June 2004, on the day before the stock market had a chance to react to positive news about a Cyberonics product. Some analysts have described the 2004 options activity as 'make-your-own-luck' grants. Others have called it springloading. On June 9, the SEC began an informal investigation into the two-year-old options.

On Friday, Cyberonics said a board committee that reviewed the company's stock option grants concluded that 'incorrect measurement dates were used for certain stock option grants made principally during the period from 1999 through 2003.'

Cyberonics estimates its financial statements from that period would need to be adjusted to reflect about $10 million in additional 'noncash compensation charges' because of the backdating activity.
It's funny how questionable financial practices seem to go hand-in-hand with dodgy marketing and strange science. In my humble opinion, cases like this suggest the urgent need for better governance of health care organizations, meaning governance that is transparent, accountable, and ethical. But given the way many helath care organizations are currently run, should it be any surprise that costs constantly go up, access constantly goes down, quality is constantly questioned, and health care professionals are increasingly miserable?

Friday, 1 July 2005

Princess Health and The Kelo Case, Pfizer, and Conflicts of Interest. Princessiccia

Princess Health and The Kelo Case, Pfizer, and Conflicts of Interest. Princessiccia

There has been quite a lot published both in main-stream media and on blogs about the Kelo case, so I have hesitated about precipitously commenting on it. However, it turns out that aspects of the case are relevant to Health Care Renewal.
The basics of the case are as follows, as per the Boston Globe. Pfizer built a large research facility in New London, CT. A not-for-profit organization, New London Development Corporation (NLDC), planned to build a "sprawling waterfront complex of private housing, stores, restaurants, and businesses" nearby in the Fort Trumbull area. Some land-owners in the area refused to sell to the NLDC, and so the city claimed their land by eminent domain. The land-owners sued the city, and the action wound up in the US Supreme Court, which decided in favor of the city, by a 5-4 vote.
Justice John Paul Stevens wrote for the majority that the city's "determination that the area was sufficiently distressed to justify a program of economic rejuventation is entitled to our deference. The city has carefully formulated an economic development plan that it believes will provide appreciable benefits to the community, including - but by no means limited to - jobs and increased revenues." This majority opinion is important, because the Fifth Amendment to the US Constitution provides "nor shall private property be taken for public use without just compensation." Many had interpreted this provision to mean that eminent domain could only be used to take property for public use, e.g., to build a road or a public school, but not for private purposes, like building up-scale waterfront developments.
In a vigorous dissenting opinion. Justice Sandra Day O'Connor wrote, "any property may now be taken for the benefit of another private party, but the fallout from this decision will not be random. The beneficiaries are likely to be those citizens with disproportionate influence and power in the political process, including large corporations and development firms.... The government now has the license to transfer property from those with fewer resources to those with more." Finally, "the specter of condemnation hangs over all property. Nothing is to prevent the state from replacing any Motel 6 with a Ritz-Carlton, any home with a shopping mall, any farm with a factory." Justice Clarence Thomas added, "allowing the government to take property solely for public purposes is bad enough, but extending the concept of public purpose to encompass any economically beneficial goal guarantees that these losses will fall disproportionately on poor communities."
For additional, important aspects of the case, see the report first published in the Wall Street Journal, September 10, 2002, and available on the web here, which details the history of what became the Kelo case. Some important points made in the article:
  • The interaction between Pfizer, the New London Development Corporation, and the city of New London was more complex than more recent reports suggest. The NLDC, which dated back to the 1970's, was taken over by new leaders in 1997. One new board member was George Milne Jr, who also was a Pfizer vice-president. The new board president was Claire Gaudiani, President of Connecticut College, the wife of David Burnett, also a Pfizer vice-president. Milne visited the Fort Trumbull site several times, but claims he recused himself from NLDC board decisions about Fort Trumbull.
  • The plan for Pfizer to build a new research facility adjacent to Fort Trumbull included contributions of $19 million by the state of Connecticut to clean up contamination on the property and a nearby scapyard, and $7 million by the city of New London and the state to lesson odors from a nearby sewage treatment plant.
  • Pfizer bought the land for the research center for only $10, and the city agreed to an 80 year real-estate and property-tax abatement.
  • Pfizer wanted the adjacent Fort Trumbull property made more attractive. In 1999, Milne wrote to the NLDC that improvement of that property "is integral to our corporate facility and to the plan for revitalization of New London to a world-class standard." Clare Gaudiani's husband, David Burnett, stated "Pfizer wants a nice place to operate. We don't want to be surrounded by tenements." (See this op-ed in the Providence Journal.)
  • The plan to re-develop Fort Trumbull came from the NLDC, not the city of New London, per se. Not only did the city council agree to the NLDC development plan for Fort Trumbull, it delegated its power of eminent domain to the NLDC, allowing this supposed private not-for-profit organization to take land from private holders.
  • Attempts by the NLDC to condemn specific properties lead to the lawsuit.
Thus, the organization which attempted to take private property by eminent domain in the Kelo case was not the city of New London, but the NLDC, an ostensibly private not-for-profit organization. This private, not-for-profit used its adopted governmental powers to apparently further the interests of a private, for-profit pharmaceutical company, Pfizer. Furthermore, the NLDC's leadership had severe conflicts of interest, specifically close ties to Pfizer, which could have affected how it used this power. None of these issues have been addressed in recent discussion of the Kelo case.
Presumably, the relationships between a large, for-profit pharmaceutical corporation and not-for-profit and government entities found in the Kelo case lead to what the Supreme Court's dissenting members felt will be a major usurpation of the rights of individuals to favor corporate interests. This case may predict similar relationships that will affect individual's rights in other circumstances, including those more specifically related to health care.
Princess Health and  The Kelo Case, Pfizer, and Conflicts of Interest.Princessiccia

Princess Health and The Kelo Case, Pfizer, and Conflicts of Interest.Princessiccia

There has been quite a lot published both in main-stream media and on blogs about the Kelo case, so I have hesitated about precipitously commenting on it. However, it turns out that aspects of the case are relevant to Health Care Renewal.
The basics of the case are as follows, as per the Boston Globe. Pfizer built a large research facility in New London, CT. A not-for-profit organization, New London Development Corporation (NLDC), planned to build a "sprawling waterfront complex of private housing, stores, restaurants, and businesses" nearby in the Fort Trumbull area. Some land-owners in the area refused to sell to the NLDC, and so the city claimed their land by eminent domain. The land-owners sued the city, and the action wound up in the US Supreme Court, which decided in favor of the city, by a 5-4 vote.
Justice John Paul Stevens wrote for the majority that the city's "determination that the area was sufficiently distressed to justify a program of economic rejuventation is entitled to our deference. The city has carefully formulated an economic development plan that it believes will provide appreciable benefits to the community, including - but by no means limited to - jobs and increased revenues." This majority opinion is important, because the Fifth Amendment to the US Constitution provides "nor shall private property be taken for public use without just compensation." Many had interpreted this provision to mean that eminent domain could only be used to take property for public use, e.g., to build a road or a public school, but not for private purposes, like building up-scale waterfront developments.
In a vigorous dissenting opinion. Justice Sandra Day O'Connor wrote, "any property may now be taken for the benefit of another private party, but the fallout from this decision will not be random. The beneficiaries are likely to be those citizens with disproportionate influence and power in the political process, including large corporations and development firms.... The government now has the license to transfer property from those with fewer resources to those with more." Finally, "the specter of condemnation hangs over all property. Nothing is to prevent the state from replacing any Motel 6 with a Ritz-Carlton, any home with a shopping mall, any farm with a factory." Justice Clarence Thomas added, "allowing the government to take property solely for public purposes is bad enough, but extending the concept of public purpose to encompass any economically beneficial goal guarantees that these losses will fall disproportionately on poor communities."
For additional, important aspects of the case, see the report first published in the Wall Street Journal, September 10, 2002, and available on the web here, which details the history of what became the Kelo case. Some important points made in the article:
  • The interaction between Pfizer, the New London Development Corporation, and the city of New London was more complex than more recent reports suggest. The NLDC, which dated back to the 1970's, was taken over by new leaders in 1997. One new board member was George Milne Jr, who also was a Pfizer vice-president. The new board president was Claire Gaudiani, President of Connecticut College, the wife of David Burnett, also a Pfizer vice-president. Milne visited the Fort Trumbull site several times, but claims he recused himself from NLDC board decisions about Fort Trumbull.
  • The plan for Pfizer to build a new research facility adjacent to Fort Trumbull included contributions of $19 million by the state of Connecticut to clean up contamination on the property and a nearby scapyard, and $7 million by the city of New London and the state to lesson odors from a nearby sewage treatment plant.
  • Pfizer bought the land for the research center for only $10, and the city agreed to an 80 year real-estate and property-tax abatement.
  • Pfizer wanted the adjacent Fort Trumbull property made more attractive. In 1999, Milne wrote to the NLDC that improvement of that property "is integral to our corporate facility and to the plan for revitalization of New London to a world-class standard." Clare Gaudiani's husband, David Burnett, stated "Pfizer wants a nice place to operate. We don't want to be surrounded by tenements." (See this op-ed in the Providence Journal.)
  • The plan to re-develop Fort Trumbull came from the NLDC, not the city of New London, per se. Not only did the city council agree to the NLDC development plan for Fort Trumbull, it delegated its power of eminent domain to the NLDC, allowing this supposed private not-for-profit organization to take land from private holders.
  • Attempts by the NLDC to condemn specific properties lead to the lawsuit.
Thus, the organization which attempted to take private property by eminent domain in the Kelo case was not the city of New London, but the NLDC, an ostensibly private not-for-profit organization. This private, not-for-profit used its adopted governmental powers to apparently further the interests of a private, for-profit pharmaceutical company, Pfizer. Furthermore, the NLDC's leadership had severe conflicts of interest, specifically close ties to Pfizer, which could have affected how it used this power. None of these issues have been addressed in recent discussion of the Kelo case.
Presumably, the relationships between a large, for-profit pharmaceutical corporation and not-for-profit and government entities found in the Kelo case lead to what the Supreme Court's dissenting members felt will be a major usurpation of the rights of individuals to favor corporate interests. This case may predict similar relationships that will affect individual's rights in other circumstances, including those more specifically related to health care.